PMS Specialist

  • Reference: 46790
  • Job Type: Permanent
  • Location: Meath
  • Category: Science, Pharmaceutical & Food

The Post Market Compliance Specialist (PMS)is responsible for ensuring the company is compliant with European Medical Device Directive and ISO:13485 with regards to Post Market Vigilance. 

PMS Responsibilities:
Functionally reports into the Regulatory Manager. You will have the responsibility for ensuring a smooth and efficient Post Market Surveillance process. The Post Market Compliance Specialist is responsible for the following main tasks:

  • Liaison for all communications with Competent Authorities for Post Market Vigilance.
  • Conduct daily complaint handling activities to include assessment of all identified potentially reportable complaints. 
  • Determine whether high risk complaints are reportable or non-reportable to the relevant Competent Authorities.
  • Hold weekly meetings with potentially reportable complaints team (product engineers, clinical, regulatory teams in USA) to gain consensus for reportable complaints to European, MEATI authorities and FDA where appropriate.
  • Liaise with Service Centres and investigation sites to ensure accurate and complete investigation and repair data is recorded. 
  • Conduct follow up for additional information to ensure complaints are documented fully and completely.
  • Monitor complaints/product deficiencies, to ensure they are categorised appropriately to high/low risk.
  • Notifying, updating and answering queries for all Competent Authorities and relevant Management teams of the progress of the Field Action.
  • Such other duties or projects as may be determined from time to time.

For more information or to apply please contact Tina Egan on 09064 78104.

Please Note: Collins McNicholas will not forward your details to any company without your prior approval.

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Tina Egan

Contact Consultant

  • Tina Egan
  • Recruitment Consultant
  • 09064 50663
  • Connect with Tina

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